Medical - Clinical Writing Team Lead

Medical - Clinical Writing Team Lead

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with more than 40,000 employees in nearly 60 countries.
Responsibilities

Acts as a Subject Matter Expert (SME), guides strategic decisions, and oversees multiple writers.
Write, review, and/or edit clinical regulatory documents such as CTD Module 2 summaries, Clinical Overviews, Clinical Study Reports (CSRs), and other regulatory documents (e.g., responses to Health Authority questions, briefing books, 120‑day Safety updates, Pediatric Investigational Plans, Investigator Brochures).
Contribute scientifically and strategically to submission teams at the project and/or study team level to facilitate efficient development of high‑quality clinical documents for regulatory filing (e.g., provide content expertise and guidance on regulatory requirements).
Translate and summarize complex biostatistical concepts and preclinical/clinical data into clear, accurate scientific reports.
Work seamlessly with cross‑functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs.
Participate in document planning meetings, timeline development, and content strategy discussions.
Oversee document timelines, ensuring projects are delivered on time and on‑budget.
Qualifications

Advanced degree in life sciences (PhD, PharmD, MD, or MS required).
Advanced regulatory/medical writing experience in the pharmaceutical industry across several therapeutics areas.
Well‑developed and proven medical writing skills.
Knowledge of regulatory document requirements and guidelines specific to ICH, FDA, and the EMA.
Ability to develop and mentor more junior medical writers.
Ability to work independently and as part of a team.
Ability to work under pressure and meet challenging deadlines.
Excellent interpersonal and presentation skills.
Advanced level of English proficiency required for this role.
Proficiency in document management tools (e.g., Veeva, MS Office).
Salary

Anticipated salary range: $123,400 - $158,670. Bonus eligible: Yes.
Benefits

Medical, dental and vision coverage.
Paid time off plan.
Health savings account (HSA).
401(k) savings plan.
Access to wages before payday with myFlexPay.
Flexible spending accounts (FSAs).
Short‑ and long‑term disability coverage.
Work‑life resources.
Paid parental leave.
Healthy lifestyle programs.
Application

Application window anticipated to close: 6/30/26. If interested in this opportunity, please submit your application as soon as possible.
Equal Opportunity/Affirmative Action Employer

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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